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OpenTrials
Terminated

NCT Number: NCT05791617

PET/MR in Post Stroke Cardiac Inflammation Study

Patients with stroke have a 25x higher risk of cardiovascular complications within the first 30 days of the event compared to individuals without stroke. The mechanisms behind these complications are not well understood. Evidence suggests that inflammation plays a central role. With the present proof-of-concept prospective cohort study, the investigators aim to demonstrate that patients develop cardiac inflammation after stroke by performing positron emission tomography (PET) magnetic resonance imaging (MRI) of the heart within 15 days after stroke. As a secondary aim, the investigators will evaluate whether post-stroke cardiac inflammation persists at 3 months after stroke. The control group will be comprised of age- and sex-matched individuals without stroke.

Why the study stopped: Study terminated prematurely due to recruitment challenges.
Terminated

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Heart & Brain Lab, Western University

London, Ontario, N6A 5A5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years willing to cons Age ≥18 years willing to consent
  • Patients with acute ischemic stroke in the right or left MCA territory, admitted to University Hospital, London Health Sciences Centre (LHSC) or evaluated at LHSC's Urgent TIA and Stroke Prevention Clinic. Acute ischemic stroke is defined as acute onset focal symptoms matching an acute brain infarct documented on a Head CT or on diffusion weighted imaging (DWI) MRI of the brain showing restricted diffusion.
  • Willing to consent.

Exclusion criteria

  • History of known heart disease defined as known atrial fibrillation, prior myocardial infarction, coronary artery disease, heart failure, prior cardiovascular surgery or percutaneous intervention
  • Stroke in the previous 3 months before the qualifying stroke.
  • High-sensitivity Troponin-T (HS-TnT) >100 ng/L on routine standard of care acute stroke bloodwork.
  • Clinically or neurologically unstable patients as per the treating physician.
  • Ongoing infection or recent infection within the previous 3 months.
  • Surgery within 3 months before the stroke.
  • Concurrent inflammatory conditions (connective tissue diseases, rheumatological disease, etc.) or use of anti-inflammatory medications.
  • Contraindications to the use of gadolinium (e.g., pregnancy, stage IV renal insufficiency)
  • Subjects will be excluded if they fail the St. Joseph's Health Care standard MRI screening questionnaire. Briefly, this questionnaire screens for: Heart Pacemakers / Wires, Aneurysm Clips, Shunt / Surgical Clips, Shrapnel / Bullets, Dentures or Metal braces, Intra-Uterine Device, Heart Valves, Ear Implants, Prostheses, Medication Patches (Nicoderm, Habitrol, Transderm-Nitro, etc.), Claustrophobia, History of a head or eye injury involving metal fragments. Patients with an eGFR < 40 will be excluded, as impaired renal function places the patient at a higher risk for a rare reaction to Gd-DTPA, the MRI contrast agent.

Treatment and study plan

Cardiac PET/MRI

Diagnostic Test

Patients will undergo cardiac PET/MRI scanning at 30±5 days and at 90±5 days post-stroke.

inflammatory markers

Diagnostic Test

Measurement of a panel of 92 systemic inflammatory markers on patients' blood samples at 30±5 days and at 90±5 days post-stroke

Other names: Olink® Target-96 inflammatory biomarker panel

Diagnostic Test: NT-proBNP

Diagnostic Test

NT-proBNP is useful both in the diagnosis and prognosis of heart failure and is considered to be a gold standard biomarker in heart failure. Measurement of NT-proBNP on patients' blood samples at 30±5 days and at 90±5 days post-stroke

Other names: N-terminal prohormone of brain natriuretic peptide

Primary outcomes

  1. Cardiac Inflammation Levels at 30±5 Days Post-Stroke measured by PET/MR Scanning

    Time frame: At 30 days±5 post stroke

    Cardiac inflammation as measure on PET/MR scanning.

  2. Cardiac Inflammation Levels at 90±5 Days Post-Stroke measured by PET/MR Scanning

    Time frame: At 90±5 days compared to first 30 days±5 post-stroke

    Cardiac inflammation as measure on PET/MR scanning.

Secondary outcomes

  1. Change in B-Type Natriuretic Peptide (NT-proBNP) and HS-TnT levels between 30±5 days and 90±5 days post-stroke.

    Time frame: At 90±5 days compared to first 30±5 days post stroke

    Change in levels of NT-proBNP and HS-TnT between 30±5 and 90±15 days post-stroke.

  2. Change in systemic inflammatory markers between 30±5 and 90±5 days post-stroke

    Time frame: At 90±5 days compared to first 30±5 days

    Systemic inflammatory markers will be measured using a high-performance biomarker panel for the following 92 proteins (all of which will be informed in pg/mL):

    ADA; ARTN; AXIN1; NGF; CCL13; CCL19; CCL2; CCL20; CCL23; CCL25; CCL28; CCL3; CCL4; CCL7; CCL8; CXCL10; CXCL11; CXCL5; CXCL6; CXCL9; CDCP1; CASP8; CST5; DNER; CCL11; EIF4EBP1; FGF19; FGF21; FGF23; FGF5; FLT3LG; CX3CL1; GDNF; CXCL1; HGF; IFNG; IL1A; IL10; IL10RA; IL10RB; IL12B; IL13; IL15RA; IL17A; IL17C; IL18; IL18R1; IL2; IL2RB; IL20; IL20RA; IL22RA1; IL24; IL33; IL4; IL5; IL6; IL7; CXCL8; MMP1; KITLG; LIF; LIFR; LTA; CSF1; SIRT2; CD244;NTF3;NRTN;OSM;CD274;S100A12;TGFA;STAMBP;SLAMF1;MMP10;SULT1A1;CD6;CD5;CD8A;TSLP;TGFB1;TNF;TNFSF10;TNFSF11;TNFSF12;TNFSF14;TNFRSF11B;CD40;TNFRSF9;PLAU;VEGFA

Sponsors and collaborators

Lead sponsor

Luciano A. Sposato

Other

Registry information

Acronym: PEPSI

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 30, 2023
Registry last updated
Sep 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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